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510(k) Data Aggregation
K Number
K040969Device Name
POISE DATAENGINE
Manufacturer
POISE TECHNOLOGY CORPORATION
Date Cleared
2004-06-08
(55 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
POISE TECHNOLOGY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DataEngine is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataEngine is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices ( independent bedside devices / information systems ) it is connected to.
Device Description
DataEngine is a comprehensive solution to integrate medical device data into HIS. It is also designed to be compatible with XML and HL7. All data collected from medical device is able to transfer to readable format of XML and HL7. Caregiver or nurses will be beneficial from DataEngine, device connectivity software to collect data in real time and receive a complete electronic data for patient's record. Medical staffs do not have to spend much time on manual script. Every patient's real time data will be stored in database server for future research projects, education, and clinical study.
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